Approximately 11% of people in the United States will have a seizure during their lifetime. Of over 100 million yearly emergency visits in the United States, 1% of adult emergency department visits and 2% of children emergency department visits are due to seizures and up to 10% of these patients may be in status epilepticus—continuous prolonged seizures with ensuing brain damage and up to 20% mortality.
Similarly, over 4 million patients are admitted every year in critical condition to intensive care units in the United States. It has been estimated that up to 34% of these critically ill patients may be in a state termed non-convulsive status epilepticus, which carries high mortality. Non-convulsive status epilepticus is a medical emergency seen in up to 34% of critically ill and comatose patients in which large numbers of brain cells start to discharge in a hypersynchronous fashion and for prolonged periods of time, leading to brain damage. This condition requires emergency management with antiseizure medications and anesthetics.
Non-convulsive status epilepticus differs from convulsive status epilepticus in that it is practically impossible to ascertain the ongoing presence of seizures because the patient does not present with clinically visible evidence. In the latter case, the patient may have continuous rhythmic jerking and/or stiffening of trunk and extremities, which can be readily observed by the clinician. Non-convulsive seizures can only be identified by the use of electroencephalography while convulsive seizures may or may not require electroencephalography to be identified.
In recent decades, the discovery of a high incidence and prevalence of convulsive and non-convulsive status epilepticus in critically ill patients has been well studied in adults and children. In addition to non-convulsive status epilepticus, a variety of abnormal brain patterns, which lie in range of the so-called ictal-interictal continuum, have been described. Although clinical effects of some of these abnormal brain patterns have been described in the literature, there remain a number of abnormal patterns of unknown clinical significance. Nonetheless, it is necessary to identify the presence of these patterns in order to adequately provide medical treatment and care. The gold standard method of identification of both normal and abnormal brain waves is electroencephalography, a technology well known in the art which makes use of a set of sensors/electrodes that are placed in contact with the scalp of a human or animal subject in order to capture the miniscule electrical signals produced by brain cells which are then processed and displayed for interpretation by a trained professional. By means of electroencephalography, brain waves can be classified into normal and abnormal, with varying degrees in between. Many specific abnormal brain patterns are known some of which include spike and waves, periodic discharges, rhythmic delta activity, among many others. Electroencephalography is well established as the most effective technology to characterize these patterns and in turn make clinical decisions.
Some abnormal brain wave patterns, such as those seen in non-convulsive status epilepticus, require emergency treatment, and failure to identify these patterns in a timely fashion can lead to irreversible brain damage and death. Due to the nature of electroencephalography (EEG) technology, often times there are delays in arriving at a diagnosis. EEG usually, but not always, involves a) a technician transporting EEG machines to the bedside; b) preparing the scalp of the patient with special gels; c) attaching a number of electrodes, usually 21, to the patient's scalp; d) recording the EEG; e) disconnecting the electrodes from the patient; f) transporting and uploading the EEG data to a server which can then be accessed and interpreted by a physician; g) communicating the results to other treating physicians. Due to this multi-step, complex process, delays in diagnosis ensue thereby translating into adverse patient outcomes. Furthermore, due to this complex endeavor, higher costs are implicit. Attempts to make this process more efficient have had varying degrees of failure and success. For example, methods to obtain “abbreviated EEG” information from only a limited number of electrodes ranging from 2 to 8 have been described but the results remain controversial with groups of clinicians finding some positive results while others discourage its use. Similarly using various electrode montage schemes which aim to make the process simpler and faster, such as the so-called “hairline montage,” have been met with skepticism. Another alternative that has been tried is the use of special helmets, headbands, head strips, headsets and caps with special arrangements of electrodes which aim to make the acquisition of EEG signals simpler and faster, however with lack of widespread support by the physician community.
One modality, is the use of continuous EEG by which patients in intensive care units are connected to EEG for prolonged periods of time but this modality still has cost-related and logistical issues, some of which include:                a) Using this modality still requires a dedicated EEG technician and mounting anywhere from 8 to 21 electrodes on the patient's scalp.        b) After initial installation, the electrodes require frequent maintenance in order to prevent the appearance of artifacts, which would make the EEG recordings undecipherable.        
Hence, it would be desirable to have an electroencephalography device that can provide an optimal-quality, safe, low-cost and efficient way of rapidly assessing the presence of abnormal electrical brain activity in emergency situations in which the current gold-standard electroencephalography technology and techniques (namely, continuous or beside 16-channel EEG) are inadequate or simply not available in emergency situations. Furthermore, it would also be desirable to have a device that allows the Clinician the ability and flexibility of performing this assessment with the least possible delay in acquisition. Still further, it would be desirable to have a device that by allowing these freedoms to the Clinician, it also significantly improves the decision-making and outcome of an acute medical intervention. Therefore, there currently exists a need in the industry for a device and associated method that allows rapid evaluation of the presence of seizures and other electrical brain abnormalities in seriously patients in the intensive care unit and emergency department.